Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Northwestern University
- Study ID
- NCT07286188
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Fibroids, Uterine
- Fluid Deficit
- Hysteroscopy / Methods
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Misoprostol Tabets — DRUG800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.
- Placebo — DRUG4 tablets of Zeebo (Microcsrystalline cellulose) placebo tablets will be placed per rectum to prior to undergoing a hysteroscopic myomectomy, for patients assigned to the placebo arm.
Study Details
The goal of this double blinded randomized control trial is to evaluate the impact of misoprostol on fluid deficit during hysteroscopic myomectomies. The main questions it aims to answer are: Is there is difference in fluid deficit in patients who receive misoprostol vs placebo pre operatively for hysteroscopic myomectomies? Participants will be randomized to received 800 mcg of either rectal misoprostol prior to their hysteroscopic myomectomy or 4 tablets of placebo (ZEEBO) prior to their hysteroscopic myomectomy.
Key Dates
- Start date
- Dec 16, 2025
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Misoprostol (treatment aem)Patients will received 800 mcg of misoprostol per rectum prior to procedure.
- Placebo Comparator: Zeebo (Placebo arm)Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.
Primary Outcome Measure
Fluid Deficit [ Time Frame: Immediately at the conclusion of the procedure. ]
Central Contacts
- Hannah Pope, MD3126946773
- Juan Avitia, MPH
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern | Chicago | Illinois | 60611 | Juan Avitia, MPH |
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